Efficacy and Safety of Eslicarbazepine Acetate as adjunctive Therapy for refractory partial seizures in a double blind, randomized, placebo-controlled, parallel-group multicenter clinical trial

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

Efficacy and Safety of Eslicarbazepine Acetate as adjunctive Therapy for refractory partial seizures in a double blind, randomized, placebo-controlled, parallel-group multicenter clinical trial

Description

This research study will examine the safety and efficacy of adding Eslicarbazepine Acetate to patients original anti epileptic regimin for those individuals whose seizure are not well controlled on their current therapy. It is a 2 part study with approximately 615 participants. Part I will follow a group with an 8 wk baseline period; a double-blind 2wk titration period; and a 12wk maintenance period. For those subjects willing there is an additional open label portion of the study that will allow the patient to participate for an additional year after part I.

Patient Inclusion Criteria:

  • 16 + years of age.
  • Documented diagnosis of epilepsy at least 12 mos prior to screen
  • At least 4 partial-onset seizures in the prior 4 weeks
  • Current treatment with 1 or 2 antiepileptic drugs (stable dose for 1 mo)

Patient Exclusion Criteria:

  • Simple partial seizures w/no motor symptomology
  • Primary generalized seizures
  • Diagnosed progressive neurological disorder
  • Seizures that occur to close together to accurately count
  • History of status epilepticus or cluster seizures
  • Seizures of non-epileptic origin
  • Previous use of Eslicarbazepine
  • Pregnant or nursing
  • Other conditions, in the opinion of the investigator, may compromise the subjects ability to comply with the study protocol

Details
Clinical Study IdentifierTX135199
Last Modified on8 November 2020

Eligibility

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note